Pre-Operative Assessment of Fusion-Related Bone Failure

融合相关骨衰竭的术前评估

• 批准号: 8780126
• 负责人: David Kopperdahl
• 金额: $ 22.5万
• 依托单位: O. N. DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-16 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8780126
• 关键词: Accounting; Address; Age; Biomechanics; Blinded; Bone Density; Case-Control Studies; Clinical; Cohort Studies; Collaborations; Cost Effectiveness Analysis; Coupled; Diagnostic; Disease; Elderly; Elements; Equilibrium; Evaluation; Failure; Fatigue; Female; Finite Element Analysis; Fracture; Geometry; Goals; Health Care Costs; Implant; Incidence; Individual; Kyphosis deformity of spine; Length; Logistic Regressions; Lordosis; Measures; Modeling; Morphology; Operative Surgical Procedures; Outcome; Patient Care; Patients; Phase; Population; Principal Component Analysis; Procedures; Pseudarthrosis; Recording of previous events; Retrospective Studies; Risk; Risk Factors; Scanning; Secondary to; Sensitivity and Specificity; Series; Small Business Innovation Research Grant; Smoking History; Spinal; Spinal Curvatures; Spinal Fractures; Spinal Fusion; Staging; Stress Tests; Surgeon; Technology; Teriparatide; Testing; United States; Vertebral Bone; Vertebral column; X-Ray Computed Tomography; base; bone; bone quality; bone strength; bone turnover; clinical practice; clinical risk; cohort; cost; cost effective; experience; high risk; improved; instrument; instrumentation; older patient; primary outcome; public health relevance; radiologist; research clinical testing; sex; spine bone structure; technology development; tool; validation studies; virtual

DESCRIPTION (provided by applicant): With over 400,000 patients undergoing spine fusion surgery each year, many of whom have low bone density because of their advanced age, it is now clear that failure of the bone after a fusion procedure is a serious and increasingly common problem. This negative outcome of the primary fusion surgery requires the patient have a second surgery, and arises because the patient's vertebral bone is too weak to sustain the loads applied to it after the primary fusion surgery. The bone can fail in different ways, the most common modes of bone failure being: 1) fracture of the adjacent-level vertebra; 2) loosening of a pedicle screw due to local failure of the supporting bone; and 3) subsidence or fracture of the vertebral endplates. These failure modes have been difficult to avoid because, although spine surgeons have a variety of both surgical and non-surgical approaches to reduce the risk of bone failure, these risk-mitigating measures add complexity and expense to the surgery and surgeons do not have an objective test to justify their use or identify which measures would be most suitable for a given high-risk patient. Thus, in the larger context of minimizing the incidence of bone failure after a spine fusion surgery, the long-term goal of this overall SBIR project is to develop new clinical tests that: 1) pre-operatively identify patients at high-risk of bone failure secondary to a fusion surgery; and 2) assess risk for each potential mode of bone failure (fracture of the adjacent-level vertebra; loosening of a pedicle screw; subsidence or fracture of the vertebral endplates). Our overall approach is based on providing a detailed biomechanical analysis of the patient's vertebrae, performed as an "add-on" analysis of the patient's pre-operative diagnostic computed tomography (CT) scan of their spine. For this Phase-I portion of the project, Aim 1 will develop a set of "virtual stress tests" of the patient's vertebrae, using fnite element analysis of the patient's CT scan. These biomechanical tests will probe each of the different types of failure modes and will account also for patient-specific measures of spine curvature and loading as well as disc morphology. These multiple tests will then be used in Aim 2, in which we will perform a retrospective blinded case-control study on over 300 spine fusion patients, for whom pre-operative CT scans have previously been acquired and clinical outcomes are on file. Finally, in Aim 3, we will perform statistical analyses to identify which of the test outcomes are most predictive of the clinical outcomes, accounting also for various clinical risk factors. We also seek to test the hypothesis that prediction of clinical outcomes by our biomechanics-based test is better than by the current best practices, setting the stage for further development of the technology in a subsequent Phase-II project. Bone failure secondary to spine fusion surgery is a serious problem. If successful, these new tests would be cost-effective to implement and would have substantial positive impact on patient care.

描述（由申请人提供）：每年有超过40万名接受脊柱融合手术的患者，其中许多人由于其高龄而患有低骨密度，现在很明显，融合手术后的骨骼失败是一个严重且日益普遍的问题。初次融合手术的这种负面结果需要患者进行第二次手术，并且由于患者的椎骨太弱而无法维持一级融合手术后的负载。骨头可能以不同的方式失败，最多 骨骼衰竭的常见模式是：1）相邻水平椎骨的断裂； 2）由于支撑骨的局部故障，松开椎弓根螺钉； 3）椎骨终结物的沉降或断裂。这些故障模式很难避免，因为尽管脊柱外科医生具有多种手术和非手术方法，以降低骨骼衰竭的风险，但这些降低风险的措施为手术增加了复杂性和费用，并且外科医生没有客观的测试来证明其使用或确定哪些措施最适合给定的高风险高危患者。因此，在最大程度地减少脊柱融合手术后骨骼衰竭的发生率的较大背景下，该总体SBIR项目的长期目标是开发新的临床测试，即：1）术前识别患者是融合手术的高风险的骨骼衰竭； 2）评估每种潜在骨骼衰竭模式的风险（相邻椎骨的断裂；松开椎弓根螺钉；椎骨终结物的沉降或断裂）。我们的总体方法是基于对患者椎骨的详细生物力学分析，以对患者脊柱的术前诊断计算机层析成像（CT）扫描进行“附加”分析。对于该项目的I阶段部分，AIM 1将使用患者CT扫描的FNITE元素分析来开发患者椎骨的一组“虚拟应力测试”。这些生物力学测试将探测每种不同类型的失败模式，还将解释特定于患者的脊柱曲率和负载以及椎间盘形态的测量。这些多个测试将在AIM 2中使用，在该AIM 2中，我们将对300多名脊柱融合患者进行回顾性盲病例对照研究，以前已经获得了术前的CT扫描，并且临床结果已存档。最后，在AIM 3中，我们将进行统计分析，以确定哪些测试结果最可预测临床结果，还考虑各种临床风险因素。我们还试图检验以下假设，即我们的基于生物力学的测试对临床结果的预测优于当前的最佳实践，这为进一步的阶段奠定了基础 在随后的II期项目中开发技术。继发于脊柱融合手术的骨失败是一个严重的问题。如果成功，这些新测试将具有成本效益，并将对患者护理产生重大积极影响。